MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BOX CHISEL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71440373
Medical Device Problem Codes	Material Fragmentation (1261); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during tka procedure three box chisels were found dull.Metal shavings were discovered to have fallen into the patient.Suction was used to retrieve the metal shavings.The case was finished using instruments but they are badly worn and not usable anymore.A delay of less than 30 min was reported.
Additional Manufacturer Narrative
The device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is dull and has signs of wear and tear from use.This case reports that during a tka surgery, three box chisels were dull and metal shavings fell inside the patient.Per email correspondence, suction was used to retrieve metal shavings.The procedure was completed using a change in technique, with no harm to the patient and minimal delay.Therefore, no further clinical assessment is warranted.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.A review of risk management file found that the reported failure was documented appropriately.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: BOX CHISEL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11362985
• Report Number: 1020279-2021-01524
• Device Sequence Number: 16419400
• Product Code: HRY
• UDI-Device Identifier: 00885556034965
• UDI-Public: 00885556034965
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71440373
• Device Catalogue Number: 71440373
• Device Lot Number: 17KSM0530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 01/27/2021; 06/01/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 04/21/2021; 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention